Z-0033-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 10, 2018
- Initiation Date
- July 31, 2018
- Termination Date
- September 20, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 43
Product Description
Capnostream20 (US)M REFURBISHED, Part Number CS78653
Reason for Recall
The date/time, nurse call and alarm settings of the bedside patient monitors may reset to the factory default settings when the monitor is powered off.
Distribution Pattern
The products were distributed US nationwide and Puerto Rico. The products were distributed to the following foreign countries: Argentina, Australia, Austria, Bahrain, Belgium, Canada, Columbia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Mexico, Netherlands, Norway, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, UAE, UK, and Vietnam.
Code Information
B300001025 B300001053 B300001106 B300001109 B300001140 B300001178 B300001219 B300001282 B300001304 B300001324 B300001262 B300001094 B300001177 B300001208 B300001242 B300001246 B300001313 B500002196 B300001188 B300001236 B300002173 B500002408 B300001071 B300001075 B300001124 B300001204 B300001248 B300001443 B500001655 B500001659 B500001660 B500001666 B500001670 B500001683 B500001701 B500001806 B500001817 B500002130 B500002189 B500002231 B300001066 B300001244 B300001207